TMBAKWEL'm Low Back Pain Relief System

To ensure the best results and long term satisfaction with your Low Back Pain Relief System werecommend that you read the following operating and maintenance instructions carefully before use.

BAKWEL™ low back pain relief system is available without prescription.

OPERATION MANUAL

Operational Manual

DO DOModel: GM320PP

Low Back Pain Relief SystemIntended UseThe Low Back Pain Relief System is intended for temporary relief of pain associated with sore andaching muscles in the lower back due to strain from exercise or normal household and work activities.

About TENS TechnologyTranscutaneous Electrical Nerve Stimulation (TENS) relieves pain by sending small electrical impulsesthrough electrodes placed on the skin to underlying nerve fibers. TENS is believed to work by twodifferent mechanisms. First, electrical stimulation of the nerve fibers can block a pain signal from beingcarried to the brain. If the signal is blocked, pain is not perceived. Secondly, the body has its ownmechanism for suppressing pain. It does this by releasing natural chemicals called endorphins in thebrain which act as analgesics. TENS may activate this mechanism.

Table of Contents

Important Safety Instructions 5-6Introduction to your Low Back Pain Relief System 7Parts of Stimulator 7How your Low Back Pain Relief System works 7Conditions that may affect your Low Back Pain Relief System 8Quick Operation Guide 8Operating Instructions 9-13How to clean your Low Back Pain Relief System 14Maintaining your Low Back Pain Relief System 14How to store your Low Back Pain Relief System 14When to Order New Pads 14Check the Low Back Pain Relief System before Using 14Warranty 15Replacement Parts 15Conformity to Standards 15Troubleshooting Guide 15Stimulator Technical Specifications 16

READ AND SAVE THESE INSTRUCTIONS:

IMPORTANT SAFETY (FORMATION:Read instruction manual before operation. Be sure to comply with all "CAUTIONS" and"WARNINGS" in the manual. Failure to follow instructions can cause harm to user or device.CAUTION: Indicates matters in which bodily harm or material damage can occur.WARNING: Indicates what you cannot do with device.Please read the following information carefully before using this Low Back Pain Relief System.AWARNNING: DO NOT USE THIS SYSTEM IF ANY OF THE FOLLOWING CONDITIONS AREPRESENT.• Do not use this System if you have a cardiac pacemaker, implanted defibrillators or any otherimplanted metallic or electronic device.

• Do not use this System if you have undiagnosed chronic pain.• If you are under the care of a physician, consult with your physician before using this System.• Do not use during pregnancy.• Do not place the pads on or close to your heart.• Do not place the pads around or close to your neck. Do not apply stimulation over the neck.Severe spasm of the muscles may occur and the contractions may be strong enough to close theairway or cause difficulty in breathing. Stimulation over the neck could also have adverse effect heartrhythm or blood pressure.

• Do not apply stimulation across the chest because the introduction of electrical current into the chestmay cause rhythm disturbances to the patient's heart, which could be lethal.

• Do not place the pads on or around your head. The effects of stimulation of the brain are unknown.• Do not use this System while sleeping.• Do not use if you feel numbness.• Do not use this System in or close to water.• Do not place the pads over or close to skin cancer.• Use the pads only on normal, healthy, clean and dry skin. Do not use the pads on open wounds orrashes, or over swollen, red, infected or inflamed skin.

• If you have ever had back surgery, consult your physician before using this System.• If you have had medical or physical treatment for your muscle pain, consult with your treatmentprovider before using this System. You should contact your physician prior to using the Systemfollowing recent surgical procedures. Stimulation may disrupt the healing process.

• Never use the stimulator and pads without the belt.

CAUTION: DISCONTINUE USE AND CONSULT YOUR PHYSICIAN IF ANY OF THE FOLLOWINGCONDITIONS APPLY TO YOU.• If you have suspected or diagnosed heart problems.• If you have suspected or diagnosed epilepsy.• If you have a tendency to bleed internally following an injury.• If areas of skin lack normal sensations, such as skin that tingles or is numb.

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• During menstruation.• The long-term effects of this System are not known.

CAUTION:• The System is intended for individual person use for the temporary relief of lower back pain.• The System is not effective for pain associated with Central Pain Syndromes, such as headaches.• The System is for pain caused by muscle soreness, and should be placed only around muscles wherepain originates on the lower back pain area.

• The pain may indicate that you have some other health problem. You should know the reason andsource of your pain before using this System. Do not solely rely on the treatment of this System forpain.

• Some people may feel skin irritation or experience a very sensitive feeling in the skin due to electricalstimulation. If this occurs, stop using your System and consult your physician.

• Some people may feel skin irritation from the adhesive on the self-adhesive pads. If this occurs, stopusing your System.

• Minor redness at stimulation placement is a normal skin reaction. It is not considered as skin irritation,and it will normally disappear within 30 minutes after the electrodes are removed. If the redness doesnot disappear after 30 minutes from the removal of electrodes, do not use the stimulator again untilafter the excessive redness has disappeared.

• Turn off the stimulator if the stimulation feels unpleasant or does not provide pain relief.• Keep your System out of the reach of children.• Do not use this System when driving, operating machinery or when swimming.• The effectiveness of the System depends greatly on a person's individual physical condition. It maynot always be effective for every user.

• Clean any adhesive residue left on the skin with soap and water. Do not use alcohol or solvent basedcleaning products on your skin.

• If skin under one of more pads feels irritated after using the stimulator for a long period of time, usethe stimulator for a shorter period of time.

• Use your stimulator only with the pads, snap cables and accessories recommended by themanufacturer.

• Before removing the belt and pads, be sure to turn OFF both power knobs to avoid unpleasantstimulation.

• If your pain does not improve, becomes more than mild, or if it continues for four to six days,stop using the device and consult your physician.

Adverse Reactions• Skin irritation and burns under the pads have been reported by some people who have appliedelectronic stimulators to their skin.

SAVE THESE INSTRUCTIONS

Introduction to your Low Back Pain Relief System

Your System includes the following parts:Support Belt

Snap Cable (1 pair)

o o o oStimulator (9V battery isincluded)Model: GM320PP

Self-adhesive pads(4 pcs) C5050

Parts of Stimulator

CH1 Output Receptacle

CH1 ON/OFF and Amplitude Control

CH2 ON/OFF and Amplitude ControlCH2 Output Receptacle

How Your Low Back Pain Relief System works:The main function of pain relief comes from the continuous stimulation pulse generated from the dualchannel stimulator. We can not ensure that the pain relief is 100% effective for everyone. However,when used according to our instruction, it can be a safe, non-addictive, non-invasive lower back painreliever.

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Conditions that may affect your Low Back Pain Relief SystemSince the stimulator is a battery-operated electronic system, its output performance and safety may beaffected greatly in extreme humidity. Therefore, it is very important to keep the stimulator dry to ensurethe safety and performance of the stimulator.

Quick Operation guideYour may use the following simple operation steps to operate this System.Step 1. Insert the 9-volt battery into your stimulatorStep 2, Prepare your support beltStep 3. Apply electrode pads to the beltStep 4. Connect the snap cablesStep 5. Adjust the length of the support beltStep 6. Put on the support belt taking care to place the self adhesive stimulator pads (now attached

to the support belt) facing toward the bare skin of one's lower back. Secure belt using itsattached hook and loop.

Step 7. Turn the stimulator "ON", adjusting the amplitude adjustment knobs to the desiredstimulation strength

Step 8. Select the therapy modeStep 9. Select the stimulation timeStep 10. Enjoy the benefitsStep 11. Turn off stimulatorStep 12. Locking and unlocking the stimulator settingsStep 13. Viewing the therapy timer

For the details of operation, please see the following operating instructions.

Description of OperationStep 1 - Insert the 9-volt battery into yourstimulatorMake sure both power knobs on stimulator areturned OFF. To insert the battery, slide front coverdownward until the cover pops off, by pushing onthe top with both thumbs. Insert a 9-volt batteryaccording to the diagram in the batterycompartment. Close the cover on the stimulator bysliding from the bottom up.IMPORTANT: Match the positive terminal ofbattery to the positive marking shown.Step 2 - Prepare your support beltLay your Support Belt open on a flat surface, withthe electrode side facing up. You will see foursquare marked areas for the self-adhesive pads.

Step 3 - Apply electrode pads to the beltElectrode Pads deliver stimulation pulses throughyour skin and into the nerves in your lower back.The pads are designed to fit within the four squaremarked areas on the Support Belt. Open thepackage of four electrode Pads. Remove thedouble side pad from the big plastic liner and thenplace the pad on the belt with the glue side down.Repeat this process with the other three pads.

IMPORTANT: Leave the smaller plastic liners onthe other side of the electrodes until step 5.IMPORTANT: Each electrode pad should beplaced exactly on the square Marked Areas, andpressed firmly onto the belt.CAUTION: Never use without all four pads onthe support belt when using the Low Back PainRelief System.

Diagram

a—Battery Strip

IBattery Compartment

• Square Marked Areas for Pads• Metal Snaps on Belt

This side facing upward.

Four electrode pads attachedto the Square Marked Areas.

Small plastic linerarger plastic liner

Small plastic liner on the top of padLarger plastic liner on the bottom of pad

Description of OperationStep 4 - Connect the snap cablesTurn the support belt over, with the electrode padsfacing down. The belt should be lying horizontally infront of you. You will see four metal snaps.

Take one cable and snap two connectors onto themetal snaps as shown in the diagram. Repeat withthe second cable.

Then plug each cable into one socket on the top ofthe stimulator. It does not matter which cable goesinto which socket.

IMPORTANT: Make sure both channel 1 andchannel 2 are turned "OFF" prior to plugging in theload cable.

Step 5 - Adjust the length of the support beltFor this System, the length of the belt is designedfor one size fits all. The belt length can be adjustedusing the hook and loop of neoprene band, asshown in the diagram.

Diagram

Fit for all support belt

Description of OperationStep 6 - Put on the support beltRemove the remaining plastic liners from the pads.Keep these liners so they can be replaced aftereach use after the Low Back Pain Relief Systemhas been used. You may now put on the belt:

1. Choose and place the support belt on theintended treatment area as described below.

2. If your lower-back pain is closer to your waistlevel than it is to the bottom of your back, placethe support belt so the middle of the belt rests atyour waist.

3. If you feel pain closer to the lower part of yourback, place the support belt so that the middleof the belt rests an inch or two below your waist.

4. Once you have the support belt in position,fasten the elastic band firmly around your torsowith the hook, pulling both ends of elastic band.

5. You can tighten or loosen the belt by adjustingthe ends of the black strap on the outside of thebelt and fastening them with their hook

Step 7 - Turn the stimulator "ON", adjusting theamplitude adjustment knobs to the desiredstimulation strengthTurn both knobs on the top of stimulator to aposition where you can feel the stimulation comingfrom each channel. The strength of stimulationshould be comfortable.The strength of stimulation may be adjusteddepending upon the individual condition of user.The stimulation output will increase as theadjustment knob is rotated toward higher outputnumbers (clockwise).1 = Weaker8 = Stronger

Diagram

Hook of flap for hiding cables

Putting on the support belt to your lower backpain position.

You can hide cables into the flap by the hookof flap as the upper drawing.

CH1

CH2

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Description of OperationStepS-Select the therapy modeThe stimulation effect can be different for differenttherapy modes. For this Low Back Pain ReliefSystem you may select the therapy mode byfollowing the instructions described below:MODE = Therapy mode selection / setting.With these buttons you can select one of eightpreset modes. With each depression of the key,you switch to the next mode. The selected modewill be shown on the LCD screen.Step 9 - Select the stimulation timeThe "TIME" button is used to set the stimulationtime. You can select between 15 min, 30 min and60min. Press the "TIME" button to toggle between15, 30, 60 minute or continuous stimulation times.The time will be shown on the pie diagram, on theLCD screen. If continuous mode, the 15 and 30symbols will on and 60 symbol will flash.Step 10 - Enjoy the benefitsAfter setting the stimulator, you can cover the beltwith clothing, being careful not to unsnap ordamage the cables. The stimulator can be clippedto your belt for portable, hands-free lower back painrelief.The stimulator will turn off automatically after thetime has expired. To restart the stimulator: turnthe adjustment knobs to the "OFF" position,wait for 7 seconds (or 20 sec if battery low) forthe stimulator to reset and turn the stimulatorback "ON" with the amplitude control knobs.Try the stimulator at different setting combinationsto find the setting that is the most effective for you.Everyone is different. For some people, thestimulator may begin to feel less effective if it isused for hours on the same settings. This canhappen if your body becomes used to the intensityor therapy mode of stimulation. You can preventthis by changing the intensity and/or therapy mode.CAUTION: While stimulating, the pads mustalways cover all four metal snaps.

Diagram

(TIME)

( T IME )

Clip the stimulator to your belt for portable.

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Description OperationStep 11 -Turning off the stimulatorIMPORTANT REMINDER: When you are finishedusing your stimulator, turn "OFF" both adjustmentknobs (counter clockwise) before removing yoursupport belt to avoid unpleasant stimulation.Replace the plastic covers on all four pads.Step 12 - Locking and unlocking the stimulatorsettingsIt is possible to lock the therapy settings of thestimulator, so they can't be changed. Make surethe stimulator is set to the settings you want to lock.Turn both power knobs on the stimulator OFF.While the stimulator is OFF, hold down the "TIME"button, then turn the stimulator ON. The unit willdisplay the current elapsed therapy time. If the unithas not been used, "0 hr" will be displayed. In orderto lock the settings of the stimulator, press the UParrow button. A lock symbol will be displayed onthe screen. The stimulator can be unlocked bypressing the UP arrow again. Turn the stimulatorOFF. If the lock symbol is displayed when you turnthe stimulator back on, you will not be able tochange the therapy settings.Step 13 - Viewing the therapy timerThere is a timer built into the stimulator that keepstrack of the amount of time the stimulator has beenused. You can view this timer by turning bothpower knobs on the stimulator OFF. While thestimulator is OFF, hold down the "TIME" button,then turn the stimulator ON. The unit will displaythe current elapsed therapy time. If the unit has notbeen used, "0 hr" will be displayed. The therapytimer can be reset to "0 hr" by pressing the DOWNarrow button. The timer only records hours oftherapy completed. If the stimulator has been usedfor less than an hour, "0 hr" will be displayed. Afterresetting the timer, turn the stimulator off. If youturn the stimulator back on without depressing theTIME button, the stimulator will function as shownin steps 7 through 10.

Diagram

/\MODE

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How to clean Your Low Back Pain Relief System Support BeltBefore washing the belt, remove the pads and put them on the storage liners. Remove the snap cablesand the stimulator from the belt. Hand-wash your Support Belt in cool water. Do not wash the belt in thewashing machine.The support belt should be air-dried, lying flat or hanging. Do not put the belt in a clothes dryer.Snap CablesDisconnect the snap cables from the belt and the stimulator. Then snap cables may be wiped with aclean, damp cloth. When re-connecting, take one snap cable, and snap its two connectors onto themetal snaps on one side of the support belt. Repeat for other side of support belt.StimulatorThe stimulator may be wiped clean with a small amount of soapy water on a clean cloth. Do notsubmerge the stimulator in liquids or expose it to ANY amount of water.Maintaining Your Low Back Pain Relief System1. Your stimulator uses a standard 9-volt battery. If stimulation seems to be weak, or the stimulator will

not turn on, check the battery. To replace the battery, make sure both amplitude control knobs areturned "OFF". Slide the stimulator cover open by pushing on the top with both thumbs until the coverslides open. Remove the old battery. Insert a 9-volt battery according to the diagram in the batterycompartment. To close the cover, slide from the bottom up.

2. Be sure to put the larger storage liners on the pads when not using your Low Back Pain ReliefSystem. You may use the storage liners provided. Replace the pads on your support belt if they nolonger stick to your skin or to the belt.

3. If your support belt is damp after use, allow it to air-dry before re-applying.4. When connecting and disconnecting a snap cable, hold it by the molded end and pull. Do not pull on

the cable itself. Replace the snap cable if worn or broken.How to Store Your Low Back Pain Relief System1. Store your Low Back Pain Relief System at room temperature in a dry place, out of the reach of

children.2. If the stimulator will not be used for more than a week, remove the battery from the stimulator.When to Order New PadsThe electrode pads are disposable and use an adhesive that will dry after prolonged usage or storage.Pads should be replaced when they lose their adhesive quality, or you sense a change in stimulationsensation. If you doubt the integrity of the pads, order new pads.To order new pads, see replacement Parts on page 15.Check the system before usingBefore using your Low Back Pain Relief System, always check all of the parts to be sure they are ingood working order. Make sure of the following:1. The battery still has power and it is not corroded.2. All four pads are in the proper place on the support belt, covering the metal snaps.3. Both snap cables are in good condition.4. Both snap cables are properly connected to the belt and the stimulator.

WarrantyThis stimulator carries a one-year warranty from the date of purchase.The warranty applies to the stimulator and necessary parts and labor relating thereto. The distributorreserves the right to replace or repair the unit at their discretion.The warranty does not apply to belt, electrode, lead wires, battery and stimulator if damage resultingfrom failure to follow the operating instructions, accidents, abuse, alterations or disassembly byunauthorized individuals.Replacement PartsContact your distributor to order replacement parts. Be sure to use only BAKWEL™ Low Back PainRelief System parts. You can check your distributor for more product information.[stimulator - Part # GM320PP [snap Cables - Part # LW02[support Belt - Part # BeltOI Pads - Part # Double side 5050

Conformity to StandardsThe Stimulator is in compliance with:• EN 60601-1 : 1990 — Safety of medical electrical equipment - General safety.•EN 60601-1-2 : EMC test• ANSI/AAMI NS 4 - 1985; Transcutaneous Electrical Nerve Stimulators.Troubleshooting GuideIf you have a problem using your Back Pain Relief System, review the following table to find a solution.

ProblemThe stimulator will not turn on.

The stimulator turns on and then off quickly.The stimulator is on, but there is no stimulation.

The display is frozen in some mode and the locksymbol appears.

The stimulator has a new 9-volt battery, but willnot turn on.

SolutionCheck the battery — be sure it is firmly in place.Change the battery if necessary.Replace the battery.

a. Check the snap cables for breakage. Ifbroken, replace,

b. Make sure the snap cables are securelysnapped onto the support belt and into thestimulator socket.

You are in "Lock" function now. The following stepswill reset the unit to normal function.1 . With unit off, press and hold down the TIME

Button.2. With the TIME button pressed, turn the unit on.3. Press the UP arrow once to turn the "LOCK"

symbol off.4. Turn unit off.5. Turn the unit on normally, it will back to normal

function.Please consult or return the device to your dealer.

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Stimulator Technical SpecificationsPower Source: 9 Volt battery.Dimensions: 108 x 61.5 x 25mm.Weight: Approx. 140 grams (battery included)

Program Max. Phase Duration Rate Function ModeP1 80mA 260us 15Hz ConstantP2 80mA 260us 2Hz BurstP3 80mA 260us 120Hz ConstantP4 80mA 260~150us 2-100Hz ModulatedP5 80mA 260us 100Hz ModulatedP6 80mA 260us 807 Hz ModulatedP7 80mA 260us 120Hz ModulatedP8 80mA P1-P7 CycleTimer: 15, 30, 60 minutes, and continuous mode selectable.

Manufacturer for:Koalaty Products, Inc.Tampa, FL. 33614, USAwww.koalatyproducts.com

Distributor/Dealer:

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